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Quality Control Inspector

3 months ago

Billerica, United States Consolidated Sterilizer Systems Full time

Consolidated Sterilizer Systems is a leading manufacturer of steam sterilization systems, providing solutions for life sciences and health care customers for more than 70 years.

We are seeking a Quality Control Inspector to ensure that all products are designed and produced according to medical device and other regulatory guidelines while meeting customer requirements, product specifications and process parameters.

**Responsibilities**:

- Develops collaborative and cooperative partnerships with various Manufacturing departments as well as Engineering, Purchasing and Operations.
- Monitors production activities to ensure compliance ASME, FDA guidelines and the company’s Quality Management System
- Inspects purchased parts, materials, assemblies, and final production. Verifies compliance by using drawing specifications.
- Ensures accurate maintenance and compliance of all quality records.
- Assists in investigating and determining root cause related to deviations, defects and complaints. Initiates corrective actions with engineering and manufacturing.
- Leads all ASME compliance activities including:

- Weekly inspection of welds, welded components, completed vessels and final assemblies to ensure ASME compliance.
- Maintenance of all ASME calibration records, receiving reports, inspection records and the QC manual.
- Performs ASME material receiving and inspection.
- Manages and maintains the NCR process.
- Maintains the accuracy of the calibration system and all inspection devices.
- Use calipers, gauges, and other tools to measure part dimensions and compare to prints.
- Document inspection results by completing reports and summarizing rework/waste.
- Assist in managing the CAPA and Complaint processes.

**Requirements**:

- 2+ years of mechanical inspection / quality control experience in a manufacturing setting required.
- Experience using calipers and tools to measure part dimensions and compare to prints required. Must possess fine motor skills and dexterity.
- Experience in a regulated environment is preferred but not required.
- Ability to read mechanical drawings, documents, and blueprints required.
- Computer proficiency required; ability to complete documentation in Microsoft Word/Excel.
- Specific vision abilities required by this job include close vision, peripheral vision, depth perception, and the ability to adjust focus.
- The employee frequently is required to use hand to finger, handle or feel objects, tools or controls and climb or balance.
- While performing the duties of this job, the employee is regularly required to stand/sit for long periods.
- The employee is occasionally required to walk; reach with hands and arms; stoop, kneel, crouch, or crawl; and talk or hear.
- The employee must regularly lift and/or move up to 10 pounds, frequently lift and /or move up to 25 pounds, and occasionally lift and/or move up to 50 pounds.

This is for a permanent full-time position, on-site, to start immediately.

**Salary/Benefits**:
Salary competitive and commensurate with experience. The benefits include working in a great atmosphere with friendly co-workers, medical, dental & vision coverage, vacation/holiday/sick time, a 401(k) retirement plan with company match, and lots of opportunity to learn new things.

**Disclaimer**:
The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.

**Benefits**:

- 401(k)
- 401(k) matching
- Dental insurance
- Flexible spending account
- Health insurance
- Life insurance
- Paid time off
- Vision insurance

Experience level:

- 2 years

Schedule:

- 8 hour shift
- Monday to Friday

Work setting:

- In-person
- Manufacturing facility
- Office
- Warehouse

Ability to Commute:

- Billerica, MA 01821 (required)

Ability to Relocate:

- Billerica, MA 01821: Relocate before starting work (required)

Work Location: In person